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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Immunohaematology (blood grouping)
/
Immunohaematology controls
/
Immunohaematology controls - other
Immunohaematology controls - other
W0103030499
20 devices
Devices
ALBAcheck® - BGS AB Serum (Human)
Alba Bioscience Limited
·
,
GB
IVD Annex II List B
CE/IVDD
ALBAcheck® - BGS Anti-D <0.1 IU/mL
Alba Bioscience Limited
·
,
GB
IVD Annex II List B
CE/IVDD
ALBAcheck® - BGS Anti-D 0.05 IU/mL
Alba Bioscience Limited
·
,
GB
IVD Annex II List B
CE/IVDD
Standard anty-D (10x2ml)
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
·
,
PL
IVD Annex II List B
CE/IVDD
ALBAcheck® - BGS High Titre Control Kit
Alba Bioscience Limited
·
,
GB
IVD General
CE/IVDD
ORTHO™ Sera Reagent Control
Alba Bioscience Limited
·
,
GB
IVD Annex II List A
CE/IVDD
ALBAcyte® Reagent Red Cells O rr
Alba Bioscience Limited
·
,
GB
IVD Annex II List A
CE/IVDD
immuClone® Rh-Hr Control IgM
IMMUCOR Medizinische Diagnostik GmbH
·
,
DE
Class D
CE/IVDR
IX 1191616-2
Active
Valid to Sep 2028
Monoclonal D Negative Control (1 X 10ml)
Lorne Laboratories Ltd
·
,
GB
IVD Annex II List A
CE/IVDD
ALBAcheck® - BGS Reagent Control for Anti-D
Alba Bioscience Limited
·
,
GB
IVD Annex II List A
CE/IVDD
immuClone® Rh-Hr Control Galileo
IMMUCOR Medizinische Diagnostik GmbH
·
,
DE
Class D
CE/IVDR
IX 1191616-2
Active
Valid to Sep 2028
Standard anty-D (1x2ml)
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
·
,
PL
IVD Annex II List B
CE/IVDD
SuperFlex D-Dimer Control
Suzhou Sym-Bio Lifescience Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Standard anty-D MIKRO (1x2ml)
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
·
,
PL
IVD Annex II List B
CE/IVDD
immuClone® Rh-Hr Control Galileo
IMMUCOR Medizinische Diagnostik GmbH
·
,
DE
Class D
CE/IVDR
IX 1191616-2
Active
Valid to Sep 2028
Standard anty-D MIKRO (10x2ml)
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
·
,
PL
IVD Annex II List B
CE/IVDD
ALBAcheck® BGS AlbaSure Sensitivity Control Kit
Alba Bioscience Limited
·
,
GB
IVD Annex II List B
CE/IVDD
immuClone® Rh-Hr Control IgM
IMMUCOR Medizinische Diagnostik GmbH
·
,
DE
Class D
CE/IVDR
IX 1191616-2
Active
Valid to Sep 2028
Control solution, for monoclonal reagents
ANTITOXIN GmbH
·
,
DE
IVD General
CE/IVDD
ALBAcyte® Reagent Red Cells O R1r
Alba Bioscience Limited
·
,
GB
IVD Annex II List A
CE/IVDD
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